Oct 1 (Reuters) - Patients taking an experimental eczema drug from Regeneron Pharmaceuticals Inc and Sanofi Inc experienced significant relief in itching and in anxiety and depression symptoms, meeting secondary goals of two large studies, researchers said on Saturday.
Regeneron and Sanofi recently asked U.S. regulators to approve the injectable medicine, Dupixent (dupilumab), after it significantly cleared skin lesions in the same pair of studies without serious side effects typically seen with standard treatments for the chronic inflammatory skin disease. The studies involved a total of 1,400 adults with moderate to severe disease.
“Reduction of itch intensity is important because itching is one of the most burdensome symptoms for patients and can impact other aspects of their lives, such as sleep,” said Dr. Eric Simpson, a dermatologist at Oregon Health & Science University who led the trials. He presented the new secondary data at the annual European Academy of Dermatology and Venereology Congress being held in Vienna.
Researchers said significant reduction in patient-reported itch was seen two weeks, four weeks and 16 weeks after treatment began, based on the Pruritus Numerical Rating Scale, which ranks itch severity on a 0- to 10-point basis.
At 16 weeks, a range of 36 to 41 percent of patients taking Dupixent either weekly or every two weeks reported a four-point or greater reduction in itch, compared with 10 to 12 percent of patients receiving placebos.
Patients taking Dupixent also reported improvement in anxiety and depression symptoms, researchers said, meeting other secondary goals of the studies.
Eczema, also called atopic dermatitis, affects an estimated 2 percent of U.S. adults, and as many as 10 percent to 20 percent of children - the majority of cases being of mild to moderate severity.
If cleared by regulators, Dupixent would be the first approved systemic treatment for eczema, which in severe cases produces infection-prone rashes and a constant itch as bad as poison ivy. Some analysts expect Dupixent to cost up to $30,000 a year and to capture eventual annual sales of more than $5 billion.
The drug works by blocking IL-4 and IL-13, proteins that Regeneron believes to be underlying causes not only of eczema, but of other allergic conditions like asthma and nasal polyps for which the drug has shown favorable results in smaller Regeneron studies.
Reporting by Ransdell Pierson; Editing by Leslie Adler